Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pamlab, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This pilot study seeks to evaluate initial evidence for the effect of L-methylfolate supplementation to OROS-Methylphenidate pharmacotherapy on ADHD symptoms and associated features in adults with ADHD, as well as tolerability of this supplementation. The investigators will conduct a 12-week double-blind randomized placebo-controlled trial with L-methylfolate supplementing open-label OROS-Methylphenidate (OROS-MPH). The investigators propose to examine 40 adult (ages 18-55) subjects satisfying the DSM-IV diagnostic criteria for ADHD.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-Methylfolate | Experimental | 15 mg of L-Methylfolate (Deplin®) daily for 12 weeks as a supplement to OROS-Methylphenidate. |
|
| Placebo | Placebo Comparator | 15 mg matched placebo comparator, with open-label OROS-Methylphenidate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-methylfolate | Drug | 15mg/day L-methylfolate. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Adult ADHD Investigator Symptom Rating Scale (AISRS) | The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54. The AISRS was compared from baseline to completion, over the course of the 12 week study. | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Craig Surman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
The total enrollment number (those who signed informed consent) was 47, however, 3 subjects were either found ineligible or lost to follow up before they could be assigned to an arm of the study. Thus 44 subjects were randomized to the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | L-Methylfolate | 15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate. |
| FG001 | Placebo (for L-Methylfolate) | 15 mg matched placebo comparator with open-label OROS-Methylphenidate |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | L-Methylfolate | 15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate. |
| BG001 | Placebo (for L-Methylfolate) | 15 mg matched placebo comparator with open-label OROS-Methylphenidate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adult ADHD Investigator Symptom Rating Scale (AISRS) | The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54. The AISRS was compared from baseline to completion, over the course of the 12 week study. | While 44 subjects were randomized to receive the study drug, only 41 subjects actually began taking the medication, and as such were evaluated using the AISRS. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
Adverse event data was collected throughout the entire time subjects were enrolled in the study beginning as their screening visit and ending at their week 12 completion visit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | L-Methylfolate | 15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Surman | Massachusetts General Hospital | 617-726-8422 | csurman@partners.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2016 | Aug 22, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2016 | Oct 3, 2017 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C005984 | 5-methyltetrahydrofolate |
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OROS-Methylphenidate | Drug | All subjects will be treated with open-label OROS-MPH |
|
|
| Placebo | Drug | 15 mg matched placebo comparator, with open-label OROS-Methylphenidate |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Ineligible |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Placebo (for L-Methylfolate) | 15 mg matched placebo comparator with open-label OROS-Methylphenidate |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 20 |
| 22 |
| EG001 | Placebo (for L-Methylfolate) | 15 mg matched placebo comparator with open-label OROS-Methylphenidate | 0 | 22 | 0 | 22 | 19 | 22 |
| Insomnia | Nervous system disorders | Systematic Assessment |
|
| Sedation | Nervous system disorders | Systematic Assessment |
|
| Cold/Infection/Allergy | Infections and infestations | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Decreased Appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Tense/Jittery | Nervous system disorders | Systematic Assessment |
|
| Nausea/Vomit/Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Neurological | Nervous system disorders | Systematic Assessment |
|
| Decreased energy | General disorders | Systematic Assessment |
|
| Mucosal Dryness | Nervous system disorders | Systematic Assessment |
|
| Anxious/worried | Psychiatric disorders | Systematic Assessment |
|
| Agitated/irritable | Psychiatric disorders | Systematic Assessment |
|
| Sad/down | Psychiatric disorders | Systematic Assessment |
|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
|
| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Genitourinary | Reproductive system and breast disorders | Systematic Assessment |
|
| Dizzy/lightheaded | Nervous system disorders | Systematic Assessment |
|
| Autonomic: Drool/sweat | Nervous system disorders | Systematic Assessment |
|
| Tics | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |